Feature Articles
The challenges of developing hematology instruments
Blood is the only fluid that flows throughout the entire human body. Blood analysis can detect a wide range of common physiological problems such as anemia, diabetes, autoimmune deficiencies, infections, and cancers. It can also expose genetic information, viruses, organ deficiencies, etc. Hematology is the study of blood cells. Hematology analyzer instruments can take the form of a relatively simple handheld unit, a more sophisticated point-of-care diagnostic instrument, or a highly complex...
Streamlining POC microfluidic molecular diagnostics
Figure 1. (a) Polycarbonate microfluidic cassette for bacteria detection in saliva. The cassette integrates a two-stage lysis process, solid-phase nucleic acid isolation, PCR with haptenized primers for post-amplification labeling, incubation for labeling of the PCR product with up-converting phosphor reporters, and blotting on a lateral-flow strip for detection of PCR product as a positive test result. The cassette features conduits, chambers (including PCR), an embedded porous silica...
Differential scanning calorimetry in molecular diagnostics
Calorimetry is the science of measuring the heat absorbed or released in a chemical reaction or physical transition. It provides a direct physical measurement of what is perhaps the most fundamental property of chemical and biochemical reactions: the change in heat.1,2 The field of calorimetry dates back to the late 18th century and the Scottish physician Joseph Black, whose work represents some of the early developments of modern thermodynamics.3 The first practical calorimeter was developed...
Extending the lifespan of IVD kits
Thermo Scientific Nunc Immobilizer Streptavidin and Nunc Immobilizer Amino surfaces. The stability of all components in an IVD kit reflects its ability to maintain consistent, and therefore accurate, performance over time. Unlike commonly measured attributes, stability is problematic to assess prior to experimental use, and as such, there is a great onus on IVD manufacturers to ensure that any stability claims are substantiated. In today’s culture of mass manufacturing, extending...
The Year in IVDs
Allegra X-30 Series Benchtop Centrifuge by Beckman Coulter The underlying themes and questions in the IVD industry during the past couple of years have been, How will the global economic downturn affect the industry, and how will IVD manufacturers overcome challenges as a result of the recession? Industry analysts continue to believe that the IVD market will not be stalled by difficult economic conditions. Nonetheless, it remains to be seen how the fallout from the recession will...
Consulting Services
In vitro diagnostics is a global business. IVD manufacturers are looking not only at the United States but also to growing economies like China and India as their future markets. Bringing a new IVD product from laboratory to market has never been easy; it involves development and implementation of good manufacturing practices and sometimes multiple regulatory submissions. These efforts are often complicated by delays in the development process, high costs, errors in design, and delays in timely...
Contract manufacturing
Contract manufacturers are described on FDA’s Web site as companies that “manufacture a finished device to another establishment’s specifications.”1 More than 1500 companies at more than 14,000 locations are currently registered with FDA as contract manufacturers.2 In addition to these companies, many other unregistered firms are also contract manufacturing nonregulated products and offering contract sterilization, repackaging, relabeling, remanufacturing, and...
Packaging and Labeling Materials and Components
IVD devices are an important part of healthcare. These devices typically contain a sample collection area on which chemical reagents or biologically active proteins react, sometimes electrochemically, with the sample to produce something that can be measured optically or photometrically. By virtue of their critical function in analyzing samples ranging from urine, saliva, and blood to swabs of cellular matter at home or in a laboratory, their reliability must remain intact. This integrity must...
Electronic and mechanical components and software
When designing an IVD or other medical instrument, most engineers look at the requirements as a group of mechanical, fluidic, electrical and software systems interacting to produce a desired result. Often, these engineers see only part of the picture. Quite a few factors come into play both during design and manufacturing and after the instrument is deployed. Following the design phase is integrating systems, performing validation, gaining approvals, manufacturing, and servicing in the field....
Tools for Molecular Diagnostics
The molecular diagnostics industry is growing rapidly, thanks to the inherent accuracy, sensitivity, specificity, and quick turnaround of molecular techniques. In addition, because of the accuracy, sensitivity, and specificity, laboratories can obtain valid results from very small amounts of specimen. This is useful for the forensic area, but also for detecting very low concentrations of target material, enabling clinicians to detect disease at a very early stage. As a result, a growing number...